NDC codes

FDA NDC Directory
Product NDC (as listed)64980-657Labeler and product segments. Claims need a package NDC.
Product NDC at billing width64980-0657Add the package segment from the table below.
Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC11-digit (billing)PackageCopy
64980-657-0164980065701100 TABLET in 1 BOTTLE (64980-657-01)Marketed from Feb 19, 2025
64980-657-10649800657101000 TABLET in 1 BOTTLE (64980-657-10)Marketed from Feb 19, 2025
64980-657-5064980065750500 TABLET in 1 BOTTLE (64980-657-50)Marketed from Feb 19, 2025

How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules

Product information

Brand name (proprietary)
Cyclobenzaprine Hydrochloride
Generic name (nonproprietary)
cyclobenzaprine hydrochloride
Active ingredients
Cyclobenzaprine hydrochloride — 10 mg/1
Dosage form
Tablet
Route
Oral
Labeler
Rising Pharma Holdings, Inc.NDC labeler code 64980
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 218936
Marketing start
Listing expires
Other FDA classes
Centrally-mediated Muscle Relaxation (Physiologic effect)
Identifiers
Product ID 64980-657_0512aebe-5f3a-4d41-9a41-7c37e001af75SPL ID 0512aebe-5f3a-4d41-9a41-7c37e001af75SPL set ID 6018b6e9-938d-4fc9-86d7-1fd1d7bfcc58RxCUI 828320, 828348UNII 0VE05JYS2PUPC 0364980655019, 0364980657013
Pharmacologic class
Muscle Relaxant

Billing references

What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.

HCPCS codeNo match

No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N464980065701 followed by a unit qualifier and the quantity

Package 64980-0657-01. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier

Product label

Current FDA label (SPL), effective .

Indications (excerpt from the label)

INDICATIONS AND USAGE Cyclobenzaprine hydrochloride tablets are indicated as an adjunct to rest and physical therapy for relief of muscle spasm associated with acute, painful musculoskeletal conditions. Improvement is manifested by relief of muscle spasm and its associated signs and symptoms, namely, pain, tenderness, limitation of motion, and restriction in activities of daily living. Cyclobenzaprine hydrochloride tablets should be used only for short periods (up to two or three weeks) because adequate evidence of effectiveness for more prolonged use is not available and because muscle spasm associated with acute, painful musculoskeletal conditions is generally of short duration and specifi…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 64980-657

What is NDC 64980-657?
64980-657 is the product NDC for Cyclobenzaprine Hydrochloride, Cyclobenzaprine hydrochloride 10 mg/1 tablet, listed with the FDA by Rising Pharma Holdings, Inc.. It has 3 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Cyclobenzaprine Hydrochloride.
What is the active ingredient?
Cyclobenzaprine hydrochloride.
Who is the labeler?
Rising Pharma Holdings, Inc., NDC labeler code 64980. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Cyclobenzaprine Hydrochloride?
223 other product NDCs are listed under this name. See all Cyclobenzaprine Hydrochloride NDCs.
Is there a related HCPCS / J-code?
Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Cyclobenzaprine Hydrochloride NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Cyclobenzaprine HydrochlorideCyclobenzaprine hydrochloride 7.5 mg/1Tablet, Film coatedOralREMEDYREPACK INC.70518-475170518-4751-00
Cyclobenzaprine HydrochlorideCyclobenzaprine hydrochloride 10 mg/1Tablet, Film coatedOralPreferred Pharmaceuticals Inc.68788-415468788-4154-0268788-4154-0368788-4154-05+2 more
Cyclobenzaprine HydrochlorideCyclobenzaprine hydrochloride 10 mg/1TabletOralREMEDYREPACK INC.70518-469270518-4692-0070518-4692-01
Cyclobenzaprine HydrochlorideCyclobenzaprine hydrochloride 10 mg/1Tablet, Film coatedOralUnit Dose Solutions, Inc.87441-01087441-0010-01
Cyclobenzaprine HydrochlorideCyclobenzaprine hydrochloride 5 mg/1Tablet, Film coatedOralCoupler LLC67046-111067046-1110-03
Cyclobenzaprine HydrochlorideCyclobenzaprine hydrochloride 15 mg/1Capsule, Extended releaseOralPreferred Pharmaceuticals Inc.68788-408768788-4087-0368788-4087-06
Cyclobenzaprine HydrochlorideCyclobenzaprine hydrochloride 5 mg/1Tablet, Film coatedOralMedcore LLC82461-71482461-0714-90
Cyclobenzaprine HydrochlorideCyclobenzaprine hydrochloride 10 mg/1Tablet, Film coatedOralMedcore LLC82461-71682461-0716-90
Cyclobenzaprine HydrochlorideCyclobenzaprine hydrochloride 10 mg/1Tablet, Film coatedOralCoupler LLC67046-164567046-1645-03
Cyclobenzaprine HydrochlorideCyclobenzaprine hydrochloride 30 mg/1Capsule, Extended releaseOralREMEDYREPACK INC.70518-452370518-4523-00

All 224 Cyclobenzaprine Hydrochloride NDCs

Other NDCs under ANDA 218936

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 218936
ProductStrengthForm · routeLabelerProduct NDC
Cyclobenzaprine HydrochlorideCyclobenzaprine hydrochloride 10 mg/1TabletOralNCS HealthCare of KY, LLC dba Vangard Labs0615-8665
Cyclobenzaprine HydrochlorideCyclobenzaprine hydrochloride 10 mg/1TabletOralREMEDYREPACK INC.70518-4692
Cyclobenzaprine HydrochlorideCyclobenzaprine hydrochloride 5 mg/1TabletOralRising Pharma Holdings, Inc.64980-655
Cyclobenzaprine HydrochlorideCyclobenzaprine hydrochloride 10 mg/1TabletOralBryant Ranch Prepack71335-2666
Fexmidcyclobenzaprine hydrochlorideCyclobenzaprine hydrochloride 7.5 mg/1TabletOralRising Pharma Holdings, Inc.64980-705

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